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GEN News Highlights : Sep 10, 2012

JV Established to Develop mAb in China

AstraZeneca’s biologics unit MedImmune and WuXi AppTec established a joint venture to develop and commercialize MedImmune’s MEDI5117 antibody therapeutic for autoimmune and inflammatory diseases for the Chinese market. The fully human IL-6-targeting monoclonal antibody has been developed using MedImmune’s YTE half-life extending technology, and is currently in Phase I studies in the U.S. and Europe. An IND application has yet to be filed in China.

Through the new equally owned joint venture, MedImmune will provide technical and development expertise relating to MEDI5117 development, with WuXi AppTec providing local regulatory, manufacturing, preclinical, and clinical trials support. The firms note that clinical development of drugs for the Chinese market requires that products not yet approved in other territories are manufactured locally. Under terms of the development agreement, AstraZeneca/MedImmune will have the option to acquire full rights to MEDI5117, but if this option isn’t exercised the joint venture will retain rights to commercialize the product. WuXi will receive fees based on services provided, and MedImmune will receive development-based milestones.

AstraZeneca says the joint venture with WuXi will enhance its drive to develop biological products in China, as part of its ongoing investment in the emerging market. “WuXi is working to build long-term drug develpment partnerships with leading biopharmaceutical companies like MedImmune to help accelerate the development of novel medicines for the large and rapidly growing Chiense pharmaceutical market,” adds Ge Li, Ph.D., chairman and CEO of WuXi AppTec.